LEECO P.A.P. - QUANT DIAGNOSTIC KIT

Acid Phosphatase (prostatic), Tartrate Inhibited

LEECO DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco P.a.p. - Quant Diagnostic Kit.

Pre-market Notification Details

Device IDK810232
510k NumberK810232
Device Name:LEECO P.A.P. - QUANT DIAGNOSTIC KIT
ClassificationAcid Phosphatase (prostatic), Tartrate Inhibited
Applicant LEECO DIAGNOSTICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJFH  
CFR Regulation Number862.1020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-01-27
Decision Date1981-02-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.